DETAILED ACTION
Applicant’s amendment and Arguments/Remarks received on 01 October 2025 have been entered. Claims 24-36 were previously pending in the application. Claim 32 has been cancelled by Applicant. Claims 24-31 and 33-36 are currently pending in the application. Claims 24, 33, 34, and 35 are independent claims. The election of Group I, drawn to a recombinant vector and a composition comprising the recombinant vector, remains in effect in the instant application. The following election of species remains in effect in the instant application:
1)e. Truncated MCK (tMCK) promoter.
Claims 34-36 remain withdrawn from consideration as being directed to a nonelected invention. Claims 24-31 and 33 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a DIV of 16/135,222, filed 19 September 2018, now U.S. Patent No. 11,446,396; which is a CON of 15/255,295, filed 02 September 2016, now U.S. Patent No. 10,105,453; which is a CON of 14/360,243, filed 22 May 2014, now U.S. Patent No. 9,434,928; which is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US12/66265, filed 21 November 2012, which claims priority to 61/563,139, filed 23 November 2011.
Thus, the earliest possible priority for the instant application is 23 November 2011.
Information Disclosure Statement
The information disclosure statements filed 01 October 2025, 01 December 2025, and 18 December 2025 have been considered by the Examiner. Examiner notes the filing of IDS Size Fee assertions for the IDS filed 01 October 2025, 01 December 2025, and 18 December 2025, as required under 37 CFR 1.98, indicating that no IDS size fee is required under 37 CFR 1.17(v) at this time.
Specification
The objection to the specification of the disclosure for reciting trade names and/or marks used in commerce without the proper symbol indicating use in commerce is withdrawn in view of the amendment to the specification Table 1 and paragraphs [0047], [0074], [0091], [0092], and [0093].
Claim Objections
The objection to claims 24-33 for reciting abbreviations without first writing out the term for which the abbreviation stands is withdrawn in view of the amendment to claims 24 and 29 writing out the terms.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 24-33 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for reciting indefinite language is withdrawn in view of Applicant’s amendments to claims 24, 29, and 31 clarifying the claims.
Claim Rejections - 35 USC § 112(a)
The rejection of claims 24-33 under 35 U.S.C. 112(a) for failing to comply with the written description requirement by claim 24 reciting a “recombinant AAV vector comprising a polynucleotide encoding alpha-sarcoglycan, wherein the polynucleotide comprises a nucleic acid sequence at least 95% identical to SEQ ID NO: 3” and claim 31 reciting, “wherein the vector comprises a AAV rh.74 capsid that comprises a sequence that is at least 95% identical to SEQ ID NO: 2”, is withdrawn in view of Applicant’s amendments to the claims such that claim 24 now recites, “wherein the polynucleotide comprises the nucleotide sequence of SEQ ID NO: 3” and claim 31 now recites, “wherein the vector comprises a AAV rh.74 capsid that comprises the amino acid sequence of SEQ ID NO: 2”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Previously presented claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Previously presented claim 25 recites, “wherein the polynucleotide sequence encoding alpha-sarcoglycan comprises the nucleotide sequence set forth in SEQ ID NO: 3”, which does not further limit claim 24, upon which it depends, because claim 24 has been amended to recite “wherein the polynucleotide comprises the nucleotide sequence of SEQ ID NO: 3”. As such, claim 24 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The rejection of amended, previously presented, and cancelled claims 24-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,434,928, hereafter referred to as the ‘928 patent, OR claim 1 of U.S. Patent No. 10,105,453, hereafter referred to as the ‘453 patent, OR claims 1-5 of U.S. Patent No. 11,446,396, hereafter referred to as the ‘396 patent, is withdrawn over cancelled claim 32 and maintained over amended and previously presented claims 24-31 and 33. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claim 24 to recite wherein the polynucleotide comprise the nucleotide sequence of SEQ ID NO: 3. However, as discussed in the prior action on pages 16-18, claims in each of the ‘928, ‘453’ and ‘369 patent recite rAAV vectors comprising nucleotide sequences having 100% identity to the sequence of instant SEQ ID NO: 3. As such, the amendments to the claims do not make the instant application patentably distinct from the ‘928, ‘453’ and ‘369 patents, and therefore do not overcome the nonstatutory double patenting rejection.
The Applicant requests that the rejection be held in abeyance until the indication of allowable subject matter. However, the instant rejection may not be held in abeyance. As set forth in MPEP 804, only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Therefore, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘928, ‘453’ and ‘369 patent claims.
The rejection of amended, previously presented, and cancelled claims 24-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,258,573, hereafter referred to as the ‘573 patent, is withdrawn over cancelled claim 32 and maintained over amended and previously presented claims 24-31 and 33. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claim 24 to recite wherein the polynucleotide comprise the nucleotide sequence of SEQ ID NO: 3. However, as discussed in the prior action, the ‘573 patent claims recite an rAAV vectors comprising a nucleotide sequence having 100% identity to the sequence of instant SEQ ID NO: 3 (‘573 SEQ ID NO: 4). As such, the amendments to the claims do not make the instant application claims patentably distinct from the ‘573 patent claims, and therefore do not overcome the nonstatutory double patenting rejection.
Applicant argues that double patenting rejections can only be made against prior filed patents and that since the ‘573 patent was awarded without a double patenting rejection to U.S. Patent No. 9,434,928, U.S. Patent No. 10,105,453, and U.S. Patent No. 11,446,396 patents, which are issued from parent/grandparent/great-grandparent priority applications to the instant application.
However, this is not agreed.
Note that the filing date of the instant application is 17 May 2022, whereas the filing date of U.S. Application No. 17/635,978, from which the ‘573 patent issued, is 21 August 2020, with priority claimed to 21 August 2019. As such, the instant application is the later-filed application.
Additionally, regarding Applicant’s argument that a lack of nonstatutory double patenting rejection over the parent ‘928, ‘453, and ‘396 patents indicates that the ‘573 patent is separately patentable from the instant application, note that the parent 928, ‘453, and ‘396 patents are all directed to methods of using the instantly claimed rAAV vector. Distinct methods of using a product do not necessarily render each other obvious; however, a lack of obviousness among such methods does not preclude each method of using a product from rending the product itself obvious.
As indicated above and discussed in the prior action, the ‘573 patent claims recite an rAAV vector comprising a nucleotide sequence having 100% identity to the sequence of instant SEQ ID NO: 3 (‘573 SEQ ID NO: 4). As such, the ‘573 claims and the instant claims are not patentably distinct from each other. A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by Applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)).
Accordingly, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘578 patent claims.
The provisional rejection of amended, previously presented, and cancelled claims 24-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/991,087, hereafter referred to as the ‘087 application, is withdrawn over cancelled claim 32 and maintained over amended and previously presented claims 24-31 and 33. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claim 24 to recite wherein the polynucleotide comprise the nucleotide sequence of SEQ ID NO: 3. However, as discussed in the prior action, the ‘087 application claims recite an rAAV vectors comprising a nucleotide sequence having 100% identity to the sequence of instant SEQ ID NO: 3 (‘087 SEQ ID NO: 4). As such, the amendments to the claims do not make the instant application claims patentably distinct from the ‘087 application claims, and therefore do not overcome the nonstatutory double patenting rejection.
Applicant argues that double patenting rejections can only be made against prior filed patent applications.
However, this is not agreed.
Note that the filing date of the instant application is 17 May 2022, whereas the filing date of the ‘087 application is 21 August 2020, with priority claimed to 21 August 2019. As such, the instant application is the later-filed application.
Further, provisional nonstatutory double patenting rejections do not require that the co-pending application have a prior effective filing date. As set forth in MPEP 804(I)(B)(1), if two (or more) pending applications are filed, in each of which a rejection of one claimed invention over the other on the ground of provisional nonstatutory double patenting (NSDP) is proper, the provisional NSDP rejection will be made in each application (emphasis added). Additionally, a complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Accordingly, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘087 application claims.
The provisional rejection of amended, previously presented, and cancelled claims 24-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-15, 17, 20, 22, 26, 63, and 66-69 of copending Application No. 18/060,263 as per claims filed on 5/22/2023, hereafter referred to as the ‘263 application, is withdrawn over cancelled claim 32 and maintained over amended and previously presented claims 24-31 and 33. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claim 24 to recite wherein the polynucleotide comprise the nucleotide sequence of SEQ ID NO: 3. However, as discussed in the prior action, the ‘263 application claims recite an rAAV vector comprising a nucleotide sequence having 100% identity to the sequence of instant SEQ ID NO: 3 (‘263 SEQ ID NO: 1). As such, the amendments to the claims do not make the instant application claims patentably distinct from the ‘263 application claims, and therefore do not overcome the nonstatutory double patenting rejection.
Applicant argues that double patenting rejections can only be made against prior filed patent applications.
However, this is not agreed.
Note that the filing date of the instant application is 17 May 2022, whereas the filing date of the ‘263 application is 30 November 2022, with priority claimed to 30 November 2021. Provisional nonstatutory double patenting rejections do not require that the co-pending application have a prior effective filing date. As set forth in MPEP 804(I)(B)(1), if two (or more) pending applications are filed, in each of which a rejection of one claimed invention over the other on the ground of provisional nonstatutory double patenting (NSDP) is proper, the provisional NSDP rejection will be made in each application (emphasis added). Additionally, a complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Accordingly, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘263 application claims.
The provisional rejection of amended, previously presented, and cancelled claims 24-33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13, 15-17, 20, 32, 38, 45, 93, 108-111, and 132-135 of copending Application No. 17/785,879, hereafter referred to as the ‘879 application, is withdrawn over cancelled claim 32 and maintained over amended and previously presented claims 24-31 and 33. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claim 24 to recite wherein the polynucleotide comprise the nucleotide sequence of SEQ ID NO: 3. However, as discussed in the prior action, the ‘879 application claims recite an rAAV vectors comprising a nucleotide sequence having 100% identity to the sequence of instant SEQ ID NO: 3 (‘879 SEQ ID NOs: 47 or 48). As such, the amendments to the claims do not make the instant application claims patentably distinct from the ‘879 application claims, and therefore do not overcome the nonstatutory double patenting rejection.
Applicant argues that double patenting rejections can only be made against prior filed patent applications.
However, this is not agreed.
Note that the filing date of the instant application is 17 May 2022, whereas the filing date of the ‘879 application is 15 June 2022, with priority claimed to 16 December 2019. Provisional nonstatutory double patenting rejections do not require that the co-pending application have a prior effective filing date. As set forth in MPEP 804(I)(B)(1), if two (or more) pending applications are filed, in each of which a rejection of one claimed invention over the other on the ground of provisional nonstatutory double patenting (NSDP) is proper, the provisional NSDP rejection will be made in each application (emphasis added). Additionally, a complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Accordingly, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘879 application claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634